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RECRUITING

NCT07071363

COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS

Sponsor: Laboratoire Dermatologique ACM

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare the dermatological tolerance and skin-lightening efficacy of a cosmetic depigmenting serum to a 4% hydroquinone-based product in adult male and female subjects aged 18-65 years with mild to moderate epidermal or mixed-type melasma. The main questions it aims to answer are: Does the cosmetic serum reduce the severity of melasma (measured by mMASI) after 84 days of use? Is the cosmetic serum better tolerated than 4% hydroquinone under real-use conditions? Researchers will compare the serum group and the hydroquinone group to determine whether the cosmetic product achieves comparable pigmentation improvement with superior skin tolerability. Participants will: Group 1: Apply a morning routine (Depiwhite Serum + Depiwhite M SPF50+ cream) Apply an evening routine (Depiwhite Serum + Placebo Cream without Hydroquinone) Group 2: Apply a morning routine (Serum Placebo + Depiwhite M SPF50+ cream) Apply an evening routine (Serum Placebo + Depigmenting Cream with hydroquinone 4%) Visit the clinical site at baseline (Day 0), Day 56, and Day 84 for assessments Complete standardized photographs, self-assessment questionnaires, and quality-of-life surveys (MELASQoL and ASLQI) Undergo clinical evaluations by a dermatologist, including mMASI scoring and tolerance assessment

Official title: COMPARATIVE EVALUATION OF THE DERMATOLOGICAL TOLERANCE AND EFFICACY OF A COSMETIC SERUM VERSUS A 4% HYDROQUINONE-BASED PRODUCT IN SUBJECTS WITH MELASMA, AFTER 84 DAYS OF USE - STUDY CONDUCTED UNDER DERMATOLOGICAL SUPERVISION

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-23

Completion Date

2025-12-22

Last Updated

2025-08-20

Healthy Volunteers

Conditions

Healthy Melasma (Facial Melasma)Epidermal Melasma

Interventions

DRUG

Depigmenting Cosmetic Serum (Applied Morning and Evening)

Participants in Group 1 receive a depigmenting cosmetic serum with non-drug actives applied morning and evening, plus a placebo cream without hydroquinone applied in the evening. Group 2 receives a placebo serum (no active depigmenting ingredients) applied morning and evening, and a hydroquinone 4% cream applied in the evening. All participants apply an SPF50+ sunscreen in the morning throughout the 84-day study. The cosmetic serum is the investigational product; hydroquinone serves as the active comparator. Placebo products are visually matched to their respective actives to ensure blinding. The study distinguishes each intervention by active ingredients, timing of application (morning/evening), and role (test vs. reference vs. supportive care). All products are applied topically, and the regimen remains fixed across the study duration.

Inclusion Criteria: Male or female subjects, primarily female, aged 18 to 65 years at the time of inclusion Fitzpatrick skin phototype II to V Diagnosed with mild to moderate epidermal or mixed-type facial melasma, confirmed by Wood's lamp examination mMASI score between 3.5 and 13 at baseline Subject is in general good health as assessed by the investigator based on medical history and clinical examination Willing to avoid excessive sun exposure and use only the provided SPF50+ sunscreen during the study Able to understand the study procedures and provide written informed consent Willing and able to comply with study procedures and scheduled visits Women of childbearing potential must agree to use a reliable method of contraception for at least 3 months prior to and during the entire study duration Exclusion Criteria: Presence of post-inflammatory hyperpigmentation (PIH), lentigines, or other non-melasma facial pigmentation Use of topical or systemic depigmenting treatments, retinoids, corticosteroids, or hormonal treatments within 4 weeks prior to baseline Known allergy or hypersensitivity to any component of the investigational or comparator products Excessive sun exposure or use of tanning beds within 2 weeks before baseline or planned during the study Active skin diseases (e.g., atopic dermatitis, psoriasis) or damaged skin in the test area Pregnant or breastfeeding women, or those planning to become pregnant during the study Participation in another clinical trial within 4 weeks prior to the study or planned participation in another trial during the study History of malignancy in the past 10 years (except treated basal cell carcinoma) Uncontrolled systemic illness (e.g., diabetes, cardiovascular, hepatic, renal, or pulmonary disease) Any psychological or cognitive condition that would limit the subject's ability to understand the study procedures Current use of photosensitizing medications BMI \> 40 or other conditions that may affect protocol compliance as judged by the investigator

Locations (1)

Centre International de Développement Pharmaceutique

Port Louis, Phoenix, Mauritius